FDA Product Code LBE: Stroller, Adaptive
Leading manufacturers include Ki Mobility, LLC.
8
Total
8
Cleared
80d
Avg days
1978
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Stroller, Adaptive Devices (Product Code LBE)
8 devices
About Product Code LBE - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code LBE since 1978, with 8 receiving FDA clearance (average review time: 80 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
LBE devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →